Cleared Traditional

K791168 - DEXIDE DISPOSABLE PREP STICK

K791168 is the FDA 510(k) clearance for DEXIDE DISPOSABLE PREP STICK by Dexide, Inc.. It is a Class 1 General Hospital device (product code KXF) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K791168 · Dexide, Inc. · General Hospital
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Jul 1979
Decision
35d
Days
Class 1
Risk

K791168 is an FDA 510(k) clearance for the DEXIDE DISPOSABLE PREP STICK. Classified as Applicator, Absorbent Tipped, Non-sterile (product code KXF), Class I - General Controls.

Submitted by Dexide, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 30, 1979 after a review of 35 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6025 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dexide, Inc. devices

Submission Details

510(k) Number K791168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1979
Decision Date July 30, 1979
Days to Decision 35 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 129d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KXF Applicator, Absorbent Tipped, Non-sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6025
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KXF Applicator, Absorbent Tipped, Non-sterile

All 7
Devices cleared under the same product code (KXF) and FDA review panel - the closest regulatory comparables to K791168.
EAR APPLICATOR, CATALOG NO. 2229
K870762 · Treace Medical, Inc. · Mar 1987
COTTON TIPPED APPLICATORS, SINGLE
K843720 · Abco Dealers, Inc. · Oct 1984
SUBCLAVIAN CATHETER INSERTION TRAY
K802580 · American Pharmaseal Div. Ahsc · Nov 1980
DEXIDE DISPOSABLE SWAB STICK
K791169 · Dexide, Inc. · Jul 1979
SHAVE PREP
K780604 · Abco Dealers, Inc. · Apr 1978
CATH KIT, SUPERPUBIC
K772227 · American Hospital Supply Corp. · Dec 1977